About

Course

The course offers an explanatory overview of the regulatory process, and the key regulatory documents produced during the process of manufacturing or clinical studies. The course deals with exhaustive knowledge of regulatory agencies of India including hierarchy and rules related to export and import of drugs in India. It also emphasis on drug regulation in different countries like USA, UK, Brazil, Australia, Japan etc. along with harmonization of all regulatory guidelines as per ICH. The course also focuses on the documentation of data and pharmacovigilance concepts of clinical studies.

Course Coordinator:

Dr. Charmy Kothari, Assistant Professor

Department of Pharmaceutical Analysis

Institute of Pharmacy, Nirma University.

Dr. Charmy S. Kothari has 10.7 years of teaching and research experience. She has 18 researches papers and review articles published in reputed Indian and International journals. She has presented various posters and a paper at international, national and state level conferences like GUJCOST, IPC, APA etc, from which one paper awarded 2nd prize for best oral presentation in state level conference Supported by GUJCOST in 2004 and She is also recipient of Dr. P. D. Sethi’s research paper certificate of merit award 2007 for the paper published in J of AOAC International. She was awarded first and second prize for best poster presentation in International conference on Applied Pharmaceutical Analysis, organized by Boston Society in the year 2014 and 2015, respectively. She has been actively involved in various capacities in organizing National and International Conferences/Workshops. She received a financial assistance from GUJCOST worth Rs. 40,000/- to organize workshop on Process Spectroscopy & Chromatography in department of Pharmaceutical Analysis. She is life member of APTI, IPA & ISTE. She is a recognized Post Graduate and Ph. D. Guide at Institute of Pharmacy, Nirma University. She has guided 15 M.Pharm students and currently guiding three Ph.D. Students. She received a minor research grants from Nirma University worth Rs.90,000/- in the year 2013 and GUJCOST worth Rs./- 5,00,000 in the year 2014. She is reviewer of national & international journal in her research area of interest. Her research areas of interest are analytical and Bioanalytical method development by DOE approach, validation and stability studies, impurity profiling and Isolation, identification and characterization of marker compounds from plants and formulations. Updates of Different regulatory Guidelines for regulatory affairs.